ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001001189

Ethics application status

Approved

Date submitted

18/06/2019

Date registered

15/07/2019

Date last updated

15/07/2019

Date data sharing statement initially provided

15/07/2019

Date results provided

15/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of a bundled care approach to preventing surgical site infections post caesarean section in an Australian Rural Hospital

Scientific title

Evaluation of a bundled care approach to preventing surgical site infections post caesarean section in an Australian Rural Hospital

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

surgical site infection

caesarean delivery

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is comprised of a caesarean infection prevention "CIP" bundle that was developed and implemented across the study population. The CIP bundle had five elements including:
1) Identification of women at risk of surgical site infection (SSI) post caesarean section (CS)
- Antenatal identification and education administered by booking midwives and medical officers
2) Pre-operative site skin preparation protocol
- No shaving, clipping if required in the operating theatre by the medical officer
- Neutral detergent bed bath prior to CS administered by the attending midwife
3) Antibiotics prophylaxis administered pre-operatively
- Cephazolin 2g Intravenously 15-60 minutes before knife to skin administered by Anaesthetics
- Clindamycin 600mg Intravenously if known MRSA carrier or cephalosporin allergy
4) Operative site skin preparation
- 2% Chlorhexidine gluconate and 70% alcohol for skin preparation
- Applied by the attending medical officer or scrub nurse prior to surgical draping
5) Negative pressure wound therapy (NPWT) for Body Mass Index (BMI) > 35
- Applied intra-operatively and left on incision wound for 7 days
- Women with BMI < 35 have standard wound dressings applied

The intervention begins prior to surgery and concludes at the end of the surgical procedure or upon removal of negative pressure dressings at day 7 for women with a BMI over 35. Participants are followed up until 30 days post operatively. The intervention is the responsibility of all clinical midwives, obstetric medical staff, anaesthetics and the Infection Control Clinical Nurse Consultant (CNC). Surveillance and adherence data is collected using a multifaceted process including review of all patients undergoing CS in the study period, emergency department encounters and hospital admissions for wound complications within a 30 day post operative period.

Intervention code [1]

Prevention

Comparator / control treatment

The control group include all women undergoing CS at the enlisted facility in the 12 month period prior to the intervention; from December 2016 to December 2017. The control group had caesareans performed:
- Without neutral detergent bed bath
- Using Povidone-iodine skin preparation
- With antibiotic administration intra-operatively without a standardised approach
- With no negative pressure wound therapy for high BMI patients

Control group

Historical

Outcomes

Primary outcome [1]

The rate of CS SSI, as defined by the CDC diagnostic criteria, following the implementation of the the CIP bundle. The CDC diagnostic criteria requires infection to occur within 30 days of the procedure AND involves the skin, subcutaneous tissue or deeper AND at least one of the following:
- Purulent drainage from the superficial incision
- Organisms identified from an aseptically-obtained specimen from the incision or subcutaneous tissue by culture or non-culture based microbiologic testing which is performed for the purposes of clinical treatment
- Superficial incision that is opened by a surgeon or attending physician and culture based testing is not performed AND the patient has one of localised pain, tenderness, swelling , erythema or heat

Timepoint [1]

The outcome is assessed at 30 days or at the point of admission for review or treatment of SSI prior to 30 days.

Secondary outcome [1]

Assess adherence to infection prevention protocols within the enlisted service. This is performed by reviewing medical records of study participants.

Timepoint [1]

30 days post CS

Eligibility

Key inclusion criteria

All women undergoing CS 12 months prior to implementation of the Bundle and all women undergoing CS 12 months post implementation of the bundle

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

There are no exclusion criteria in this study

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed. This is a translational research project where the CIP bundle is implemented as routine practice.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

retrospective data was collected on all women delivering via Caesarean Section in the 12 month period directly prior to implementation of the bundled intervention

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Univariate analyses will be conducted to assess for differences in the populations in the pre and post intervention groups. Univariate analyses will be conducted to test for differences in demographic and comorbidity variables or interest, between those that develop SSI and those that do not. CS and SSI rates will be compared pre and post intervention using t-tests and logistic regression models. The non-parametric Wilcoxon rank sum test will be used where there are small numbers of observations.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/12/2017

Date of last participant enrolment

Anticipated

Actual

31/12/2018

Date of last data collection

Anticipated

Actual

5/07/2019

Sample size

Target

710

Accrual to date

Final

710

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Tamworth Rural Referral Hospital - Tamworth

Recruitment postcode(s) [1]

2340 - Tamworth

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Tamworth Regional Referral Hospital - Tamworth

Address

Corner of Dean Street and Johnson Street
North Tamworth, NSW 2340

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Health District Human Research Ethics Committee

Ethics committee address [1]

Locked bag 1
Hunter Region Mail Centre
Newcastle, NSW, 2300

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/01/2018

Approval date [1]

16/04/2018

Ethics approval number [1]

169133

Summary

Brief summary

Elective and non-elective caesarean section (CS) rates have been increasing in Australia over the past 20 years. Increasing antenatal morbidity, has meant that surgical site infection (SSI) post CS is an important issue effecting Australian women. Populations most impacted include low socioeconomic and regional communities where high rates of antenatal comorbidity augment the incidence of SSI. Despite a recent trend towards supporting the development of evidence based bundled approaches to SSI reduction, there remains paucity in data proving efficacy and supporting bundle implementation.

This study aimed to develop, implement and assess an evidence based caesarean infection prevention “CIP” bundled intervention to reduce SSI rates following CS in a high risk rural population.

The study is a pre-post intervention study with 3 phases and included all women undergoing CS at a regional referral hospital between December 1st 2016 and December 31st 2018. A 12 month retrospective pre-intervention review identified all women who developed a post CS SSI. A comprehensive literature review informed the development of the intervention, which was implementation in December 2017. Prospective data collection for a subsequent 12 month period was collected on all women who underwent CS with pre and post comparative data analysis.

Trial website

Trial related presentations / publications

Public notes

This project was an implementation project involving embedded practice change within a whole service. No formal recruitment was required as all patients undergoing CS received the "CIP"  bundle of care once the practice change was implemented. Ethics approval was for the formal evaluation and involved retrospective data collection of the pre implementation group.

Contacts

Principal investigator

Name

Mrs Michelle Bolte

Address

Tamworth Rural Referrral Hospital
Corner of Dean and Johnson St, North Tamworth NSW 2340

Country

Australia

Phone

+61 2 67677185

Fax

michelle.bolte@health.nsw.gov.au

Contact person for public queries

Name

Michelle Bolte

Address

Tamworth Rural Referrral Hospital
Dean St, North Tamworth NSW 2340

Country

Australia

Phone

+61 2 67677185

Fax

michelle.bolte@health.nsw.gov.au

Contact person for scientific queries

Name

Michelle Giles

Address

Hunter New England Health
Nursing and Midwifery Research Centre
Gate Cottage
72 Watt Street Newcastle, 2300
NSW

Country

Australia

Phone

+61 0457710429

Fax

michelle.giles@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data accessible to research team only

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2364	Ethical approval					377772-(Uploaded-25-06-2019-09-20-21)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Reducing surgical site infections post-caesarean section in an Australian hospital, using a bundled care approach.	2020	https://dx.doi.org/10.1016/j.idh.2020.01.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically